(143 days)
The Nurochek-Pro System is intended for prescription use in healthcare facilities for subjects aged between 12 and 44 years old. for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment.
The Nurochek-Pro System is indicated for the generation of visual evoked potentials (VEP) and to acquire, transmit, display, and store electroencephalograms (EEG) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain iniury (mTBI) in subjects aged between 12 and 44 years old who have sustained a potential head injury in the past 120 hours (5 days).
The Nurochek-Pro System is a portable system designed to generate visual evoked potentials (VEPs) in patients and acquire, transmit, display, and store the resulting electroencephalogram (EEG). It is intended for prescription use in healthcare facilities, by healthcare professionals, on subjects aged between 12 and 44 years old, to aid in the diagnosis of mild traumatic brain injury (mTBI). The primary components of the Nurochek-Pro System are the wearable headset, the Nurochek-Pro Software Application, and the Nurochek-Pro Server.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (Nurochek-Pro System) |
|---|---|
| Sensitivity | 0.8551 (85.51%) with a 95% confidence interval of (0.7496, 0.9283) |
| Specificity | 0.6705 (67.05%) with a 95% confidence interval of (0.5621, 0.7670) |
| Positive Predictive Value (PPV) | 67.0% |
| Negative Predictive Value (NPV) | 85.5% |
| Ability to differentiate between subjects with and without mTBI | "The study demonstrated that the device can differentiate between subjects with and without mTBI." |
Study Details
-
Sample size used for the test set and data provenance:
- Sample Size: 157 individual steady-state visual-evoked potential (SSVEP) readings.
- Data Provenance: Not explicitly stated, but the study involved "study subjects (age range 12-49 years)" and the clinical research protocol required readings to be collected within 120 hours of suspected head injury, in addition to a clinical evaluation by a licensed physician. This suggests prospective data collection in a clinical setting. The manufacturer is Headsafe MFG Pty Ltd. in Australia, which may imply data origin.
-
Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Not explicitly stated as a specific number. However, the ground truth was established by "Each highly trained physician". This implies multiple physicians were involved.
- Qualifications of Experts: "highly trained physician" who used "their education and experience to deliver their mTBI determination." This likely includes neurologists or emergency medicine physicians, given the context of mTBI diagnosis.
-
Adjudication method for the test set:
- Adjudication Method: Not explicitly stated if a formal adjudication method (like 2+1 or 3+1) was used. The text mentions "Each highly trained physician used their education and experience to deliver their mTBI determination." This suggests individual clinical determination, but not necessarily a consensus or tie-breaking process.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: Not explicitly stated that an MRMC comparative effectiveness study was conducted involving human readers with and without AI assistance. The study described focuses on the device's standalone performance against clinical diagnosis.
- Effect Size: Therefore, no effect size for human reader improvement with AI assistance is provided.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the described performance (Sensitivity, Specificity, PPV, NPV) represents the standalone performance of the Nurochek-Pro System's classification algorithm. The clinical investigation aimed to "evaluate the performance of the Nurochek-Pro System against clinical diagnosis."
-
The type of ground truth used:
- Ground Truth Type: Clinical diagnosis by a licensed healthcare professional. This diagnosis was based on "a neurological examination, a concussion-related signs and symptom evaluation, and a review of all relevant information provided by the study subject in relation to their injury."
-
The sample size for the training set:
- Sample Size: 272 individual steady-state visual-evoked potential (SSVEP) readings.
-
How the ground truth for the training set was established:
- Training Set Ground Truth: The text states, "The Headsafe classification Algorithm used in this device was generated with 272 individual steady-state visual-evoked potential (SSVEP) readings, in which there was a 24.6% prevalence of mTBI." While not explicitly detailed for the training set ground truth establishment, it can be inferred that a similar process involving clinical evaluation by licensed physicians (as described for the validation set) was used to establish the mTBI status for the cases used to generate the algorithm. The "clinical research protocol required readings to be collected within 120 hours of the suspected head injury, in addition to a clinical evaluation by a licensed physician" applies to the study subjects from which the database was generated.
§ 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.
(a)
Identification. A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
(ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.
(2) The device parts that contact the patient must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical safety, electromagnetic compatibility (EMC), thermal, and mechanical safety.
(4) Clinical performance testing must demonstrate the accuracy, precision-repeatability and reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs).
(5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the study prevalence per the device intended use.
(6) The device design must include safeguards to ensure appropriate clinical interpretation of the device output (
e.g., use in appropriate patient population, or for appropriate clinical decision).(7) The labeling and training information must include:
(i) A warning that the device is not to be used as a stand-alone diagnostic.
(ii) A detailed summary of the clinical performance testing, including any adverse events and complications.
(iii) The intended use population and the intended use environment.
(iv) Any instructions technicians should convey to patients regarding the collection of EEG data.
(v) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway.
(vi) Information allowing clinicians to understand how to integrate the device output into their diagnostic pathway when the device is unable to provide a classification or final result.